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Page 1: Legal Status of Cannabinoids in end-user products on EU market

Thispresenta,onwilladdresslegalstatusofhempseedderiva,vesandhempcannabinoidsfromtheperspec,veofinterna,onallaw.Somelocalna,onalspecificsmayandwesuggestyoucontactyourna,onalofficialsfordetails.

Page 2: Legal Status of Cannabinoids in end-user products on EU market

Let’sbeginwithali?lemathema,cs101.Everybodyinthisroomisfamiliarwithpercent,representedbyabrownsquareona10x10board.1%equalsto10000partspermillion.

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Page 3: Legal Status of Cannabinoids in end-user products on EU market

Nowlet’smovedownonedecimalpoint.Weareshowinga“magical”0.2percentvalue.

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Let’smovedownonedecimalpointagain.0.01percent,oroneoftenthousand,isnotreallyasignificantvalueinourdiscussion.

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Nowlet’sjumptwodecimalpointsandwearrivetoapart-per-million.Youmayimagineitastwoburnt-outpixelsonaFullHDscreenwhichhasroughly2millionpixels.

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Wehavefinallyarrivedto100parts-per-billionor100microgramsperkilogramor0.10ppm.Youmayimagineitasoneburnt-outpixelonfiveFull-HDscreenscombined.

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ThistablegivesabriefoverviewofvariousEUlimitsforcontaminantsintwotypesofhempfoods:oilanddryproducts.NotesomecontaminantssuchasDioxinsaretestedonppblevel.

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Andthisisalistofpes,cideshempseedshouldbetestedfor,withcorrespondinglimitsinmg/kg.

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LowestObservedEffectLevel"(LOEL)and“AcceptableDailyIntake”(ADI)arecommonlyappliedwhendevelopingstandardsintendedtopreventundesiredsideeffectsfromchemicals.LOEListhelowestdatapointatwhichtherewasanobservedeffect.Wemaycallitplaceboeffect.SucheffectsofTHCaredescribedintheliteratureastemporary,mildtomoderatepsychomotororcogni,veeffects.ThetermAcceptableDailyIntake(ADI)isusedtodescribesafedailyintakeofasubstancethatmaybedeliberatelyaddedtofoodoranunavoidablecontaminant.Itiscalculatedbymul,plyingtheLOELbyanuncertaintyfactor.Thistablegivesabriefcomparisononpoliciesorscien,ficopinionsonTHCADI.WestartwithGermanpolicyfromyear2000,thenpresentEFSA’sopinionsin2011and2015.Pleasenotedecreaseofsafetyfactorfrom100to30.EIHAproposesthatahumancanallowtakingtwoLOELdosesofTHCperdaysincepoten,aleffectsofTHChaveadura,onfor6hours.EIHAalsoproposessafetyfactorloweredto20resul,nginADIroundedto240microgramsperday.PleaseseeforcomparisonEFSA’sopiniononopiumalkaloidsinpoppyseed.WithLOELverysimilartothatofTHC,ADIismany,meshigherbecauseoflowsafetyfactor.IsTHCreallythatmuchmorepoten,allyharmfulthanMorphine?

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Byusingconsump,ondataofvariouskindsoffoods,suchasfatsandoils,highvolumeproteinorcarbohydrate-basedfoods,lowvolumefoodsandvarietyofdrinks,presentedvaluesforfinalproductsarebeingproposed.Asyoucansee,adailyintakeofhemps,llleavesuswithamarginof3.96microgramsofTHCfromADIof240mcgperday.

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HereweshowfinalproposedvaluesforingredientstradedonaB2Bmarket.Wealsoshowexis,ngguidancevaluesorlimitsinsomeEUcountriesoroutsideofEurope.

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DifferentSchedulesdescribepoten,alofabuseandmedicinaluse.

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“Cannabisplant”meansanyplantofthegenusCannabis.Legalindustrialcul,varsusuallycontainlessthen0.2%ofTHC(0.3%inCanada).UpperthirdpartofCannabisplantisusedfortes,ngcannabinoidprofileforassessmentofdrugtypevsfibertype.THC,CannabinolandCannabidiolaretakenintoaccountwithresultoftheformulahigherorlowerthan1.

“Cannabis”meansthefloweringorfrui,ngtopsofthecannabisplant(excludingtheseedsandleaves)fromwhichtheresinhasnotbeenextracted,bywhatevernametheymaybedesignated.

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“Produc3on”meansthesepara,onof…cannabisandcannabisresinfromtheplantsfromwhichtheyareobtained.

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“Manufacture”meansallprocesses,otherthanproduc,on,bywhichdrugsmaybeobtainedandincludesrefiningaswellasthetransforma,onofdrugsintootherdrugs.

“Extracts”and“Tinctures”of“Cannabis”aredefinedasScheduleInarco,cdrugs.“CBD-OIL”=CannabisextractunderUNOSingleConven3on.Whenperformingsuchac,vi,eseverybodyshouldbewellawareofthena,onallegisla,onsinacountrywherethisishappening.Sinceextrac,onalsoincreasesTHCcontent,theuseofcannabisextractand,ncturesonB2Cmarketisillegalorextremelygrey.OurCBDisola,onfacilityinPraguehasagovernmentlicenseforextrac,onandwearenotallowedtoselltheextract,notevenonB2Bmarket,onlytoen,,eswiththelicensetohandlenarco,candpsychotropicsubstances.

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Pleasenotethat95%puritylevelisthedis,nguishingpointbetweenextractsandchemicalsubstances.Whateversubstanceisisolatedfromanyherbalsourceoverthislevel,canbecalleda“chemical”withitsformulaandCASdatabasenumber.Fromperspec,veoflegisla,onitdoesnotma?erifitisofherbalorsynthe,corigin.

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ByTHCcri,calwemeanthis.Doyouwantyourfoodproducttoappearonthislist?SeethatproductsarebeingpulledfromshelvesforTHClevelaround1ppm.

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Isthisreallytheproperwayofsafeandresponsiblemarke,ngofcannabisextracts?

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